Cellenkos Inc, a clinical-stage biotechnology company focused on regulatory T cell (Treg) therapies, has received clearance from the US Food and Drug Administration (FDA) for its Investigational New Drug (IND) application to initiate a Phase 1b/2a clinical trial of CK0802. The therapy is being developed for patients suffering from steroid-refractory Graft-versus-Host Disease (GVHD), a serious and often life-threatening complication following allogeneic stem cell transplantation.
GVHD occurs when donor immune cells attack healthy tissues in the recipient’s body, commonly affecting the skin, gastrointestinal tract and liver. Standard first-line treatment relies on high-dose corticosteroids; however, nearly half of patients do not respond adequately. Existing second-line therapies often provide limited and temporary benefit, leaving patients with poor survival outcomes and highlighting the urgent need for new treatment approaches.
The planned multicenter, open-label study will evaluate the safety, tolerability and early signs of effectiveness of CK0802 through multiple infusions. The trial will enroll patients who have not responded sufficiently to steroid therapy after transplantation. The primary endpoint will assess safety and overall response rate at Day 29. The study is expected to begin in the second half of 2026, with initial results anticipated in early 2027.
CK0802 is an investigational, off-the-shelf Treg therapy derived from cord blood and designed to function effectively in high-inflammatory environments. The therapy works by restoring immune balance through multiple mechanisms, including suppressing inflammatory signals, reducing harmful immune cell activity and promoting long-term immune regulation. Its ready-to-use format is intended to enable timely treatment in critical care settings where rapid intervention is essential.
Commenting on the development, Simrit Parmar, Founder of Cellenkos and faculty at Texas A&M University, stated that advancing CK0802 into clinical trials represents an important step toward addressing a significant unmet medical need in transplant care. Tara Sadeghi, Chief Operating Officer, added that the regulatory clearance reflects confidence in the company’s clinical and manufacturing data, and will support further development of the therapy. Earlier clinical findings in critically ill patients experiencing severe inflammatory conditions demonstrated encouraging safety and survival outcomes, supporting continued investigation of CK0802 in GVHD.
Cellenkos Inc is a Houston-based biotechnology company developing Treg-based therapies for inflammatory and autoimmune diseases. Its pipeline includes programs targeting conditions such as aplastic anemia, neurodegenerative disorders and metabolic diseases, supported by its proprietary CRANE® manufacturing platform.
